Device Classification Name |
screw, fixation, bone
|
510(k) Number |
K122489 |
Device Name |
EMERGE MEDICAL SOLID BONE SCREWS |
Applicant |
EMERGE MEDICAL |
790 S. COLORADO BLVD |
SUITE 550-S |
DENVER,
CO
80246
|
|
Applicant Contact |
VICTORIA TRAFKA |
Correspondent |
EMERGE MEDICAL |
790 S. COLORADO BLVD |
SUITE 550-S |
DENVER,
CO
80246
|
|
Correspondent Contact |
VICTORIA TRAFKA |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 08/15/2012 |
Decision Date | 12/10/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|